Methylphenidate HCl Oral Solution

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Overview

What is Methylphenidate HCl Oral Solution?

Methylphenidate HCl Oral Solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is

Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.

Each mL of Methylphenidate HCl Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP.

Each mL of Methylphenidate HCl Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP.

In addition, Methylphenidate HCl Oral Solution also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water.

What does Methylphenidate HCl Oral Solution look like?

What are the available doses of Methylphenidate HCl Oral Solution?

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What should I talk to my health care provider before I take Methylphenidate HCl Oral Solution?

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How should I use Methylphenidate HCl Oral Solution?

Attention Deficit Disorders, Narcolepsy

Attention Deficit Disorders

Methylphenidate HCl Oral Solution is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.

Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.

Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.

Dosage should be individualized according to the needs and responses of the patient.

Adults

Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children (6 years and over)

Methylphenidate HCl Oral Solution should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.

Methylphenidate HCl Oral Solution should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

What interacts with Methylphenidate HCl Oral Solution?

Marked anxiety, tension, and agitation are contraindications to Methylphenidate HCl Oral Solution, since the drug may aggravate these symptoms. Methylphenidate HCl Oral Solution is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.

Methylphenidate HCl Oral Solution is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

What are the warnings of Methylphenidate HCl Oral Solution?

Serious Cardiovascular Events

Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

Adults

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation): Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon

Stimulants, including Methylphenidate HCl Oral Solution, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

USE IN CHILDREN LESS THAN SIX YEARS OF AGE

Methylphenidate HCl Oral Solution should not be used in children under six years, since safety and efficacy in this age group have not been established.

What are the precautions of Methylphenidate HCl Oral Solution?

General

Patients with an element of agitation may react adversely; discontinue therapy if necessary.

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Methylphenidate HCl Oral Solution should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with Methylphenidate HCl Oral Solution is usually not indicated.

Long-term effects of Methylphenidate HCl Oral Solution in children have not been well established.

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Instruct patients beginning treatment with Methylphenidate HCl Oral Solution about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
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Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate HCl Oral Solution.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Methylphenidate HCl Oral Solution. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Priapism

Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism).

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Drug Interactions

Methylphenidate HCl Oral Solution may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.

Human pharmacologic studies have shown that Methylphenidate HCl Oral Solution may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Methylphenidate HCl Oral Solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 2.5 times the maximum recommended human dose on a mg/kg and mg/m basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Methylphenidate did not cause any increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 4 times the maximum recommended human dose on a mg/kg and mg/m basis, respectively.

Methylphenidate was not mutagenic in the Ames reverse mutation assay or in the mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an assay in cultured Chinese Hamster Ovary (CHO) cells. The genotoxic potential of methylphenidate has not been evaluated in an assay.

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Usage in Pregnancy

Adequate animal reproduction studies to establish safe use of Methylphenidate HCl Oral Solution during pregnancy have not been conducted. However, in a recently conducted study, methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 167 times and 78 times the maximum recommended human dose on a mg/kg and a mg/m basis, respectively. In rats, teratogenic effects were not seen when the drug was given in doses of 75 mg/kg/day, which is approximately 62.5 and 13.5 times the maximum recommended human dose on a mg/kg and a mg/m basis, respectively. Therefore, until more information is available, methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.

What are the side effects of Methylphenidate HCl Oral Solution?

Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolsis. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to severe hepatic injury; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss; serotonin syndrome in combination with serotonergic drugs. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

What should I look out for while using Methylphenidate HCl Oral Solution?

Marked anxiety, tension, and agitation are contraindications to Methylphenidate HCl Oral Solution, since the drug may aggravate these symptoms. Methylphenidate HCl Oral Solution is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.

Methylphenidate HCl Oral Solution is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Serious Cardiovascular Events

Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

Adults

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

–

Bipolar Illness

–

Emergence of New Psychotic or Manic Symptoms

–

Aggression

–

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation): Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon

Stimulants, including Methylphenidate HCl Oral Solution, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

USE IN CHILDREN LESS THAN SIX YEARS OF AGE

Methylphenidate HCl Oral Solution should not be used in children under six years, since safety and efficacy in this age group have not been established.

What might happen if I take too much Methylphenidate HCl Oral Solution?

Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes, and rhabdomyolysis.

Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.

How should I store and handle Methylphenidate HCl Oral Solution?

Store at 25°C (77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.Methylphenidate HCl Oral Solution 5 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3005-50Methylphenidate HCl Oral Solution 10 mg per 5 mL is available as a colorless, grape flavored liquid.Bottles of 500 mL NDC 0406-3010-50Dispense in tight container with child-resistant closure.Storage:Ritalin is a registered trademark of Novartis Corporation.Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2017 Mallinckrodt.Manufactured by: SpecGx LLC Webster Groves, MO 63119 USA L20M56Rev 08/2017 MallinckrodtAn electronic copy of this medication guide can be obtained from or by calling 1-800-778-7898 for alternate delivery options.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Methylphenidate is a racemic mixture comprised of the and enantiomers. The enantiomer is more pharmacologically active than the enantiomer.

Methylphenidate HCl is a central nervous system (CNS) stimulant.

The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

There is neither specific evidence which clearly establishes the mechanism whereby Methylphenidate HCl Oral Solution produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Non-Clinical Toxicology

Marked anxiety, tension, and agitation are contraindications to Methylphenidate HCl Oral Solution, since the drug may aggravate these symptoms. Methylphenidate HCl Oral Solution is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.

Methylphenidate HCl Oral Solution is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).

Serious Cardiovascular Events

Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

Adults

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

–

Bipolar Illness

–

Emergence of New Psychotic or Manic Symptoms

–

Aggression

–

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation): Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon

Stimulants, including Methylphenidate HCl Oral Solution, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

USE IN CHILDREN LESS THAN SIX YEARS OF AGE

Methylphenidate HCl Oral Solution should not be used in children under six years, since safety and efficacy in this age group have not been established.

Methylphenidate HCl Oral Solution may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.

Human pharmacologic studies have shown that Methylphenidate HCl Oral Solution may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Methylphenidate HCl Oral Solution.

Patients with an element of agitation may react adversely; discontinue therapy if necessary.

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Methylphenidate HCl Oral Solution should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with Methylphenidate HCl Oral Solution is usually not indicated.

Long-term effects of Methylphenidate HCl Oral Solution in children have not been well established.

Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy; libido changes; and rhabdomyolsis. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to severe hepatic injury; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss; serotonin syndrome in combination with serotonergic drugs. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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